Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
This study has been completed.
Sponsor:
Theradex
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00111904
First received: May 26, 2005
Last updated: December 13, 2011
Last verified: June 2009
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Purpose
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: paclitaxel-loaded polymeric micelle |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Time to progression [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Best overall response rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Clinical benefit [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 43 |
| Study Start Date: | May 2005 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the time to progression and time to treatment failure in patients with unresectable locally advanced or metastatic epithelial carcinoma of the pancreas treated with paclitaxel loaded polymeric micelle (Genexol^®-PM).
- Determine the best overall response rate and duration of response in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
- Determine the clinical benefit and safety of this drug in these patients.
OUTLINE: Patients receive paclitaxel loaded polymeric micelle (Genexol^®-PM) IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed epithelial carcinoma of the pancreas
- Unresectable* locally advanced or metastatic disease NOTE: *Documented by high-quality contrast-enhanced CT scan
- No known or clinical evidence of CNS metastasis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ
- No unstable or serious medical condition
- No psychiatric disorder that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
No prior chemotherapy for pancreatic cancer
- Prior fluorouracil as a radiosensitizer allowed
Endocrine therapy
- Not specified
Radiotherapy
More than 6 weeks since prior radiotherapy for pancreatic cancer
- Disease must have progressed after completion of radiotherapy
Surgery
- More than 14 days since prior major surgery and recovered
Other
- More than 30 days since prior investigational agents
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111904
Locations
| United States, Florida | |
| Florida Cancer Specialists - Bonita Springs | |
| Bonita Springs, Florida, United States, 34135 | |
| United States, Illinois | |
| Midwest Cancer Research Group, Incorporated | |
| Skokie, Illinois, United States, 60077 | |
| United States, Louisiana | |
| Louisiana Oncology Associates - Lafayette | |
| Lafayette, Louisiana, United States, 70506 | |
| United States, New York | |
| St. Vincent's Comprehensive Cancer Center - Manhattan | |
| New York, New York, United States, 10011 | |
| United States, Texas | |
| Southwest Regional Cancer Center - Central | |
| Austin, Texas, United States, 78705 | |
Sponsors and Collaborators
Theradex
Investigators
| Study Chair: | John S. MacDonald, MD | Beth Israel Comprehensive Cancer Center - West Side Campus |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00111904 History of Changes |
| Other Study ID Numbers: | CDR0000433513, TARGET-S04-10485, WIRB-20050099 |
| Study First Received: | May 26, 2005 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III pancreatic cancer recurrent pancreatic cancer stage IV pancreatic cancer |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Paclitaxel |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013